Digital wipes and method of handling

ABSTRACT

A new and useful digital wipe structure, and method for handling the wipe structure, are provided that is particularly useful in forming and handling a an oral wipe to clean teeth and gums, especially a young child&#39;s teeth and gums. A digital wipe structure comprises a piece of material impregnated with an oral therapeutic solution, and configured to be wrapped completely about a user&#39;s index finger to provide a sleeve about the user&#39;s index finger. The wipe structure is further configured so that when wrapped about a user&#39;s index finger an outer portion of the sleeve is oriented so that pressure from the user&#39;s thumb will hold stabilize the sleeve and maintain the sleeve on the user&#39;s index finger, preferably against the middle or distal phalanx. The digital wipe structure can form an oral wipe that can be efficiently produced, and easily handled by a user to produce a wipe that is impregnated with an oral therapeutic solution and can be formed into a sleeve that can be effectively stabilized on a user&#39;s finger (preferably against the middle or distal phalanx), and effectively used to clean a person&#39;s teeth and gums. Moreover, a preferred wipe can be folded into a pattern that enables the wipe to be effectively packaged, and effectively unfolded and formed into a sleeve that can be stabilized on a user&#39;s finger, despite the fact that the wipe is impregnated with an oral therapeutic solution

RELATED APPLICATION/CLAIM OF PRIORITY

This application is related to and claims priority from ProvisionalApplication Ser. No. 60/574,515, filed May 26, 2004, and entitledDigital Wipes and Method of Handling, which provisional application isincorporated by reference herein.

BACKGROUND

The present invention relates to a new and useful digital wipestructure, to a method of handling a wipe structure, and particularly toan oral wipe that can be simply produced and effectively handled toclean the teeth, gums, tongue, and oral mucosa. In addition, the presentinvention provides an oral digital wiping process, that provides a newand useful technique for accurately delivering an oral therapeuticmaterial to the oral cavity.

In applicant's experience as a pediatrician, there has been a need toprovide a simple and effective way of cleaning the teeth, gums, tongue,and oral mucosa, especially in young children. However, applicant hasalso learned of a number of issues that have to be confronted in thedesign of an oral wipe for such purposes. For example, U.S. Pat. No.6,721,987 describes a number of issues that have to be addressed in thedesign of an oral cleaning device for removing films and residues (e.g.plaque) from a person's teeth. The patent describes the inconvenienceoften associated with carrying a toothbrush, and finding an appropriatefacility in which to use the toothbrush. Moreover, the patent describesissues involved in designing a dental wipe as an alternative to atoothbrush, e.g. designing a dental wipe that can be effectivelymaintained on a user's finger without slippage, as well as the need toefficiently manufacture the dental wipe. Applicant further notes thatsuch issues are particularly applicable to an oral wipe that isimpregnated (effectively saturated) with a mouth rinse solution, andintended to be used to clean the oral cavity, and in the process tophysically remove retained food particles as well as biofilms such asdental plaque while simultaneously applying therapeutic substances suchas antimicrobial agents, as well as other therapeutic substances, to theteeth, gums, tongue, and oral mucosa.

In addition, in applicant's experience, existing methods for deliveringan oral therapeutic material to the oral cavity for preventing andtreating various oral disease conditions including dental caries, dentaldiscoloration, gum disease, teething pain, oral pain, and oral thrushcan also be significantly improved upon, through a delivery system thatutilizes a digital oral wipe to more precisely deliver the therapeuticmaterial to the mouth. In this application, reference to an “oraltherapeutic material” means a material that is applied to any or all ofa person's teeth, gums, tongue and oral mucosa (e.g. the soft tissueinside the person's cheek). The oral therapeutical material wouldinclude any or all of (i) a mouth wash, preferably with a non cariogenicor anti cariogenic material, (ii) an antimicrobial material, e.g. anantifungicide, or an antibiotic material, and (iii) an anestheticmaterial. Reference to an “oral therapeutic solution” means a solutionthat includes an oral therapeutic material.

SUMMARY OF THE INVENTION

The present invention provides a new and useful digital wipe structure,and method for handling the wipe structure, that can be used to form anoral wipe that is efficient to produce and effective to clean the oralcavity, including the removal of dental plaque and biofilms from theteeth, gums, tongue, and oral mucosa.

In addition, the present invention provides a digital wiping process,particularly for the oral cavity, that provides a new and useful processfor delivering an oral therapeutic material to the teeth, gums, tongue,and oral mucosa.

A digital wipe structure according to the present invention, when formedas an oral wipe, comprises a piece of material impregnated with an oraltherapeutic solution, and configured to be wrapped completely about auser's index finger to provide a sleeve about the user's index finger.The digital wipe structure is further configured so that when wrappedabout a user's index finger an outer portion of the sleeve is orientedso that pressure from the user's thumb will hold and stabilize thesleeve and maintain the sleeve on the user's index finger. The digitalwipe structure is then in a condition to accurately and effectivelyapply wiping pressure and an oral therapeutic material to a localizedarea, particularly an area where accurate wiping pressure and/orapplication of an oral therapeutic material is desirable or necessary.

An oral wipe according to the present invention can be efficientlyproduced, and effectively handled by a user to form a piece of materialthat is impregnated with an oral therapeutic solution into a sleeve thatcan be effectively stabilized on a user's finger, and effectively usedto clean and apply the oral therapeutic material to a person's oralcavity.

Moreover, a preferred oral wipe can be folded into a pattern thatenables the wipe to be efficiently packaged, and effectively unfoldedand formed into a sleeve that can be stabilized on a user's finger,despite the fact that the oral wipe is impregnated with an oraltherapeutic solution.

In addition, the present invention provides a new and useful way ofdelivering an oral therapeutic material that includes an antimicrobialmaterial (e.g. nystatin) to the oral mucosal surface of a patient,particularly a patient that is affected by oral thrush.

Other features of the present invention will become further apparentfrom the following detailed description and the accompanying drawingsand exhibits.

BRIEF DESCRIPTION OF THE DRAWINGS AND EXHIBITS

FIG. 1 is a schematic three dimensional view of an oral wipe,constructed according to the principles of the present invention;

FIG. 2 is a top view of the oral wipe of FIG. 1;

FIG. 3 is a side view of the oral wipe of FIG. 1;

FIG. 4 is a schematic view of oral wipe according to the presentinvention, in a folded condition, and disposed in a packet;

FIG. 5 is a schematic top view of an oral wipe according to the presentinvention, and showing the lines upon which the dental wipe is folded,according to the principles of the present invention;

FIG. 6 is a schematic illustration, showing the manner in which an oralwipe, according to the present invention, can be unfolded: and

FIGS. 7-11 are schematic illustrations, showing the manner in which thewipe is wrapped about a user's index finger, according to the principlesof the present invention.

Exhibits A-H are color illustrations of a digital wipe and a method ofhandling the digital wipe, according to the principles of the presentinvention (in those Exhibits, some numbering, along the lines of thefigures, is provided).

DETAILED DESCRIPTION

As discussed above, the present invention relates to a new and usefuldigital wipe structure that is particularly useful as an oral wipe, andto a method for handling the wipe, that is efficient to produce andeffective to use to clean and apply therapeutic materials to the teeth,gums, tongue, and oral mucosa. The principles of the invention aredescribed herein in connection with a preferred form of an oral wipe,but it will be clear to those in the art how those principles can beused in the configuration and handling of various types of digital wipestructures.

An oral wipe 100, configured according to the present invention, isillustrated in the FIGS. 1-11 and Exhibits A-H. The oral wipe 100comprises a flat piece of material 102 that is configured in accordancewith the principles of the present invention and which is impregnatedwith an oral therapeutic solution. The piece of material 102 can be madefrom woven or non-woven absorbent material, and is preferably of acellulosic or synthetic material similar to the type of material that istypically used to form paper towels or synthetic fiber towels. Also, thepiece of material can be textured on the side of the material that isintended to rub against the teeth and gums of a child. It has beencommon for some time to make textured material by texturing a sheet ofmaterial so that the material is textured on both sides, but for thepurposes of the present invention, it is preferred, but not required,that if the piece of material is textured, it only needs to be texturedon the side that is intended to be rubbed against a person's teeth,gums, tongue, and oral mucosa in order to facilitate biofilm removal.

The piece of material 102 is configured to be wrapped completely about auser's index finger to provide a sleeve 113 about the user's indexfinger, and is further configured so that when wrapped about a user'sindex finger an outer portion of the sleeve is oriented so that pressurefrom the user's thumb stabilizes the sleeve 113 and maintains the sleeveon the user's index finger (preferably against the middle phalanx ordistal phalanx of the index finger). FIG. 9 (and Exhibit F) show thesheet of material wound into a sleeve about a user's index finger, andstabilized by the user's thumb (against the middle phalanx of the indexfinger).

Moreover, the piece of material 102 is preferably configured so thatwhen the sleeve 113 is wrapped about the user's index finger, the sleeveextends at least from the distal tip of the user's finger to a locationthat is past the middle inter phalangeal joint of the user's indexfinger (typically the middle inter phalangeal joint is between theproximal and middle phalanges of the finger). FIG. 9 (Exhibit F) showthe sleeve being wrapped about a user's index finger, with the sleeveextending past the middle inter phalangeal joint of the user's finger(the approximate location of the middle inter phalangeal joint is shownby the dashed line 117).

As seen from FIGS. 1-3, 5 and Exhibits B, C, the piece of material 102preferably has a parallelogram shape. The piece of material 102 has apair of parallel sides, 104, 106, and another pair of parallel sides108, 110. Adjacent sides 104, 108 form an acute angle end portion 112,and adjacent sides 106, 110 form another acute angle end portion 114.Each of the acute angle end portions 112, 114 defines an acute anglethat is preferably between 40 and 70 degrees.

In addition, each of the parallel sides 104, 106 preferably has a lengthof at least 4 inches, and is preferably about 5 inches. Also, the height115 of the piece of material (see FIG. 2,) is at least 2.5 inches, andis preferably at least 2.75 inches. Still further, each of the parallelsides 108, 110 has a length of about 3.5-4 inches. A piece of materialthat has a parallelogram configuration, with parallel sides 104, 106,acute angle end portions 112, 114 and a height 115 with the foregoingdimensions, can be effectively formed into a sleeve in the mannerdescribed herein.

The parallelogram configuration of the piece of material 102 isparticularly useful in facilitating wrapping the piece of material intoa sleeve about a user's finger. One of the acute angle end portions 112,114 can be used as a lead point to initiate wrapping of the piece ofmaterial about a user's index finger (see FIGS. 7-8, Exhibit E, wherewrapping is initiated about the finger at the upper end of theillustration) and the other acute angle portion will form a trailingpoint that overlies the remainder of the sleeve and which can be engagedby a user's thumb to stabilize the sleeve on the user's index finger,preferably against the middle phalanx (see FIG. 9, Exhibit F).

Additionally, the piece of material 102 is large enough that when it iswrapped into a sleeve about a user's index finger, the sleeve can have adistal end 116 that extends past the distal tip of the user's finger(see FIG. 9, Exhibit F), where the approximate distal tip of the user'sfinger is shown by dashed line 119) and can be bent back over the sleeveand captured between the user's thumb and the sleeve, to stabilize thesleeve and maintain the sleeve on the user's finger, preferably againstthe middle or distal phalanx (see FIGS. 10, 11, Exhibits G, H). Whenwrapped and stabilized in this manner, the wipe provides additionalsurface area that can be rubbed against a person's teeth or gums (or anyother part of an oral cavity).

Moreover, while a parallelogram configuration with acute angles ispreferred (because it can also produce the leading and trailing endsthat are useful in folding and packaging the wipe, as described below),it will be clear to those in the art that the wrapping process describedabove can also be practiced with a rectangular wipe (with 90 degreerather than acute angles), so long as the dimensions of the rectangularwipe are sufficient to enable the wipe to provide a sleeve with anoverlapped portion (FIG. 9. Exhibit F), and a distal end portion thatextends beyond the end of the user's finger (FIG. 9, Exhibit F), and canbe folded back and stabilized by the user's thumb, in the mannerdescribed above (FIGS. 10-11, Exhibits G, H).

As described above, the piece of material is impregnated (and preferablysaturated) with an oral therapeutic solution. Preferably, the oraltherapeutic solution includes a non-cariogenic or an anti-cariogenicagent such as xylitol or fluoride. An example of one formulation for theoral therapeutic solution is shown in the following table: MaterialAmount (%) Supplier Purified water 58.8 Widely available Xylitol(xylitol C) 25.0 Danisco, USA Inc., 440 Saw Mill River Road, Ardsley NY10502 Sorbitol, USP 70% 10.0 Widely available solution Glycerin, USP 5.0Widely Available Sodium Benzoate, USP 0.200 Widely AvailableHydroxyethyl Cellulose 0.500 Amerchol, Inc (Amerchol Cellosize(subsidiary of Union HEC QP-40) Carbide, Inc.), PO Box 1206, Midland, MI48642 Natural & Artificial 0.300 Essential Ingredients, Grape flavorInc., 4544 Atwater Ct., (medallion Formula Suite 110, Beaufort, #2179)GA 30518 Trisodium Citrate 0.180 Cargil, Inc., 400 Diehl Dihydrate, USP(Tri- Rd., Maplesville, IL sodium Citrate 60563 Dihydrate USP/FCC, FineGranular) Citric Acid, USP 0.020 Widely available

In addition, the oral therapeutic solution can be formulated to containanti-microbial agents such as nystatin USP (an antifungal agent) as atherapy for oral yeast infections (which are often found in children),or various antibiotics (e.g., penicillin, tetracycline) or antiseptics(chlorhexadiene) for local application to oral infections.Anti-inflamatory agents such as corticosteroids (e.g. hydrocortisone)can be added to treat certain inflammatory conditions such as mouthsores or apthous ulcers. Also, flavoring agents can be used, and whenthe dental wipe is specially designed for adult use, cleansingsurfactants, dental whitening agents, re-calcifying agents, and/orcertain types of mouth freshening agents (e.g. ethanol, menthol)) can beincluded in the mouth rinse solution. Anesthetic agents (e.g.benzocaine, lidocaine) could also be incorporated into the wipe solutionto treat painful oral lesions or to treat teething pain in children. Thesheet of material can be impregnated with the oral therapeutic solutioneither before it is folded or after it is folded, in the mannerdescribed herein.

The piece of material 102, which has the unfolded parallelogramconfiguration described above, can be folded into a predetermined foldedconfiguration (see FIGS. 4-6 and Exhibits A-D). It is desirable to foldthe piece of material into the configuration shown in FIG. 4, when theoral wipe is to be distributed in individual packets (a packet 120 isoutlined schematically in dashed lines in FIG. 4 and Exhibit A). FIG. 5(and Exhibit B) show in dashed lines the pattern from which the piece ofmaterial can be folded into the configuration of FIG. 4. Specifically,the piece of material can be initially folded along fold lines 122 thatare parallel to the height 115 of the piece of material and where theinitial fold incorporates one of the acute angle end portions 112, 114.The folding continues in an accordion fashion along the parallel foldlines 122 and thereafter the piece of material is folded along a centerfold 140 that leaves the other of the angle end portions 112, 114 on theoutside of the folded piece of material (see FIG. 4 and Exhibit A). FIG.6 and Exhibit C show the piece of material prior to the fold alongcenter fold line 140, and FIG. 6 and Exhibit D show a folded sheet ofmaterial partially unfolded to show the accordion nature of the foldsabout fold lines 122.

The parallelogram shape of the piece of material is particularly usefulwhen the piece of material is in the folded configuration of FIG. 4 (andExhibit A). In that folded configuration, at least one of the acuteangle end portions 112, 114 overlies the remainder of the folded pieceof material and provides a convenient gripping portion to enable thepiece of material to be conveniently unfolded. This feature isparticularly useful with a piece of material that is impregnated withoral therapeutic solution, since the wet material might otherwise bedifficult to grip when the material is being unfolded. Moreover, theparallelogram shaped piece of material is also useful in facilitatingthe material impregnated with the oral therapeutic solution beingwrapped about a user's index finger to form a sleeve on the user's indexfinger, and in providing a convenient trailing point that can be engagedby a user's thumb to stabilize the sleeve on the user's index finger(see e.g. FIGS. 7-11 and Exhibits E-H). As explained in U.S. Pat. No.6,721,987, maintaining a dental wipe on a user's finger while resistingslippage of the dental wipe is a significant issue, and the presentinvention addresses that issue with an oral wipe structure that issimple and efficient to produce and effective to handle to accuratelywipe and apply oral therapeutic solution to a localized area of aperson's mouth.

Thus, as seen from the foregoing description, the present inventionprovides a wipe structure, and method of handling the wipe structure,that is particularly useful in forming an oral wipe that is impregnatedwith an oral therapeutic rinse solution and which is wrapped into asleeve about a user's index finger and stabilized by the user's thumb.In view of the foregoing description, it is believed that variousmodifications and adaptations of the present invention will be apparentto those in the art. For example, while it is preferred to wrap thesleeve about a user's index finger, the sleeve can also be wrapped aboutthe user's index and middle fingers, and stabilized by the user's thumbin the manner described above. Also, while the disclosed parallelogramshaped piece of material is preferred, in light of the foregoingdescription, it is expected that other configurations of a piece ofmaterial that can be used to form a digital dental wipe that can beimpregnated with an oral therapeutic solution, folded and unfolded, andwrapped into a sleeve on a user's index finger, and stabilized on theuser's finger, will be apparent to those in the art. For example, otherconfigurations for a sheet of material that can form lead and trailingpoints that enable the structure to be effectively folded and unfolded,wrapped about an index finger and stabilized with a user's thumb will beapparent to those in the art.

In addition the principles of the present invention, as described above,while particularly useful as an oral wipe, may also be useful informing, packaging and handling other types of digital wipe structures,where such wipe structures are intended to be impregnated with oraltherapeutic solution, formed into a sleeve on a user's index finger andstabilized against slippage on the user's finger, so that they can beaccurately and effectively apply wiping pressure and deliver an oraltherapeutic solution to a localized area, particularly an area whereaccurate wiping pressure and/or oral therapeutic solution is desirableor necessary. For example, the principles of the present invention maybe useful in the production and handling of digital wipe structures forcleansing and debridement of skin wounds, for the careful application ofa substance to the face or other irregular body surface (e.g. earlobe,nostril or eyelid), or the local application of the wipe to a mechanicaldevice in which other areas of the mechanical device need to not bedisturbed or touched by the wipe. Thus, various applications of theprinciples of the present invention will be apparent to those in theart.

Furthermore, the inventor-pediatrician is particularly interested infacilitating the prevention and treatment of oral disease conditions ininfancy through the use of the digital oral wipe. It is proposed thatthe digital oral wipe may be especially useful in addressing three ofthe most common oral conditions of early childhood: early childhoodcaries, oral candidiasis, and teething syndrome.

The Centers for Disease Control have reported that dental caries is themost common infectious disease of children, affecting as many as fortypercent of children by five years of age. Early childhood caries(cavities) are caused by various mouth bacteria, most importantlyStreptococcus mutans (MS). This bacterium begins to colonize the mouthas soon as the baby teeth erupt, typically at age six months. MS hasadapted to the local ecology of the tooth enamel surface through itsability to form complex biofilms referred to as dental plaque, whichadhere and propagate on all tooth surfaces. The plaque biofilm secretesorganic acids that demineralize (decalcify) the tooth enamel resultingin erosions and pits on the teeth, which in turn allows progressivesequestration of the plaque colony deeper into the tooth structure. Thisdisease process begins in infancy, but may be interrupted in a timelyway through the application of proper oral hygiene practices to removeplaque from the baby teeth. Currently parents are restricted to usinginfant toothbrushes and finger cots which are not always convenient touse, or a wet washcloth or gauze pad which is not always hygienic, toclean the primary dentition (baby teeth). In addition, most dentalprofessionals do not recommend the use of fluoride containing productsin children less than two years of age due to the risk of fluorosis(staining) of the teeth. Recent advances in dental science havesuggested that xylitol, a natural sugar alcohol found in many fruits andvegetables, may inhibit the propagation of MS plaque colonies. Xylitol,instead of fluoride, can readily be incorporated into a mouthrinsesolution, which can be used to saturate the oral wipe. The digital oralwipe can be particularly effective to physically remove dental plaquefrom the anterior primary dentition, which consists of the flat,spade-like incisors. The xylitol solution diffuses into the plaquebiofilm where it may be active as an inhibitor of MS energy pathways(i.e. may inhibit simple sugar fermentation with production of organicacid by-products). Thus the oral wipe may be conveniently used ininfancy as an initial application of an oral hygiene practice that mayhelp prevent the long term establishment of MS plaque forming coloniesin the mouth of the child.

The present invention also provides a new and useful way of deliveringan oral therapeutic solution that includes an antimicrobial material(e.g. nystatin) to the mucosal surface (e.g. the gums) of a patient,particularly a child that is affected by oral thrush.

Oral thrush, referred to as oropharyngeal candidiasis in the medicalliterature, in otherwise healthy infants is an extremely common disease,estimated to occur in 15% of one-month-old infants. This mouth infectionis caused by Candida species (mainly Candida albicans) which areclassified as yeast fungi. The yeast microbe can be transmitted to theinfant during birth via the mother's birth canal, or after birth viamaternal candidal skin colonization at the breast, or through maternalsaliva where Candida species are normal colonizers. By 6 months of agemost healthy infants become less susceptible to oral thrush. By thisage, Candida species become a normal component of the orointestinalflora in many humans, but no longer cause disease except in patientswith diabetes mellitus, or in situations where immunodeficiency occurs,such as HIV infection or patients receiving chemotherapy.

The oropharyngeal infection by Candida albicans typically presents aswhitish patches or pseudomembranes adhering to the oral mucosa insidethe cheeks, and on the gum surfaces and the tongue. With some effort,these tenaciously adherent membranes can be physically scrapped off toreveal a reddened erosive base. Analysis of the candidal pseudomembranesreveals they consist largely of sloughed mucosal cells, white bloodcells, fungal elements including spores and hyphae, as well as keratinand food debris. As the oral infection progresses, these inflammatorypsuedomembranes may become confluent, covering larger and largersurfaces of the oral mucosa. The infant with oral thrush may experiencemouth discomfort and pain, with poor feeding and loss of appetite. Theinfection is self limited in healthy infants, and will often resolvespontaneously within two weeks, but in some cases may persist for up totwo months. Most medical authorities agree that oral thrush in infancyshould be treated, especially if the infant is irritable and not feedingwell. Oropharyngeal candidiasis in immunocompromised patients shouldalways be treated due to the potential of the infection to spread to theesophagus, and even into the bloodstream.

Treatment of oral thrush includes antifungal drugs classified aspolyenes (nystatin, amphotericin B) or imidazoles (miconazole,clotrimazole, fluconazole, ketoconazole, itraconazole). The polyene,nystatin, given orally is not absorbed by the gastrointestinal tract,thus its mode of action is through direct contact with the candidalpseudomembranes in the mouth. The drug is typically delivered to themouth as liquid nystatin suspension in a concentration of 100,000 unitsper milliliter. The suspension is squirted into the baby's mouth with amedicine dropper. The usual dosage is two dropperfuls (2 ml. or 200,000units) four times per day for ten to fourteen days. One dropperful isapplied to each inner cheek or buccal surface of the baby's mouth witheach dose. Because nystatin does not adhere to the oral mucosa, the timethat the drug is actively in contact with the infected surface can behighly variable. In most cases, the nystatin is quickly swallowed by theinfant, resulting in suboptimal contact time. In contrast, olderchildren and adults can actively retain and swish the nystatinthroughout the mouth, insuring a longer contact time. The candidalpsuedomembrane itself may serve as a protective cap or barrier to thepenetration and diffusion of the drug through the pseudomembrane matrix,preventing the drug from reaching the active fungal elements at thesurface of the oral mucosa. Clinical cure rates using this nystatindosing regimen are variously reported as 50-85% following a ten daycourse of treatment. Relapses requiring re-treatment occur in 20-30% ofcases.

Due to its relatively high cost as compared to nystatin, the imidazole,fluconazole is primarily indicated for patients failing to respond tonystatin, or for more severe cases of oropharyngeal candidiasis. Unlikenystatin, fluconazole is absorbed via the intestinal tract, and thus itsmode of action is not dependent on direct contact with the yeastbiofilm. Nystatin suspension continues to be the drug of choice for oralthrush in infancy because of its low cost (˜$15.00 per treatment) andextremely low incidence of side effects coupled with a long history ofsafe usage in early infancy.

By using an oral wipe according to the present invention, thenon-absorbable polyene antifungal, nystatin, in which drug efficacy isdependent upon direct contact with the infected mucosal surface, can bedelivered to the infection site more efficaciously by direct physicalapplication of the antifungal agent to the oral mucosal membranes. Thus,the wipe becomes a unique drug delivery system for an antimicrobialmaterial such as nystatin. By saturating a disposable oral applicatorsuch as a wipe, swab, or sponge with sufficient antifungal solution andapplying the solution directly to the candidal pseudomembranes, it isexpected that the overall efficacy of therapy will improve. Moreover, inapplying an antimicrobial material such as nystatin, while the oral wipedescribed in this application is preferred, it is believed that thisaspect of the present invention can also be practiced with disposableoral wipes of the types that exist in the art, by saturating such wipeswith a solution that includes nystatin, and using the wipes to applypressure to and to wipe against a mucosal surface such as an infantpatient's gums. For example, an oral wipe can be saturated with two tothree milliliters of nystatin suspension, and upon digital applicationto the mouth, using pressure and wiping action, will release one to twomilliliters of the antifungal drug (100,000-200,000 units of nystatin)into the mouth. Furthermore, by using an oral wipe as preferred above,and wrapping the nystatin saturated wipe around the index finger of theperson applying the wipe to the infant's mouth, the wipe can bephysically manipulated over the mucosal surfaces covered by the candidalpseudomembranes. By applying continuous back and forth digital pressureto the infected membranes, a debridement action will result, whereby thepseudomembranes are at least partially disrupted, providing increasedexposure of the pseudomembrane surfaces to the antifungal drug, as wellas providing open conduits for the drug to be delivered through thepseudomembrane barrier to the inflamed oral mucosal surface. Debridementhas long been an advisable therapeutic maneuver in the management ofdamaged or infected epithelial surfaces. Examples include the scrubbingof skin surfaces superficially infected by bacterial pathogens(impetigo) or the sponge cleansing of skin abrasions and burns prior tothe application of topical anti-infectives. By using a nystatinsaturated oral wipe of the type described above (or other antimicrobialsaturated oral applicator), the processes of oral lesion debridement andsimultaneous application of an anti-infective are combined into oneefficient and effective process.

Accordingly, the present invention provides a new and useful oral wipestructure and method, and also a new and useful way of applying anantibacterial material (e.g. nystatin) to the mucosal surface of apatient, particularly an infant patient. With the foregoing disclosurein mind, it is believed that various ways to configure and handle adental wipe, and also to apply an antimicrobial material (e.g. nystatin)to a patient's mucosal surface, particularly an infant's mucosalsurface, will become apparent to those in the art.

Finally, it is intended that the digital oral wipe may also be saturatedwith an oral therapeutic solution that includes a topical anestheticsuch as benzocaine to provide to infants and young children a method forrelieving pain associated with teething. Current methods of deliveringtopical anesthetic generally rely on squeezing a gel or paste with theanesthetic onto a finger or directly onto an aral lesion, and then usinga bare finger to apply the anesthetic. An oral wipe according to theinvention that is saturated with an oral therapeutic solution containingtopical anesthetic, a more hygienic option for parents to apply the painrelieving substance to the infant's teeth and gums.

1. An oral wipe comprising a piece of material impregnated with an oraltherapeutic solution, the piece of material configured to be wrappedcompletely about a user's index finger to provide a sleeve about theuser's index finger, and further configured so that when wrapped about auser's index finger an outer portion of the sleeve is oriented so thatpressure from the user's thumb will stabilize the sleeve and maintainthe sleeve on the user's index finger.
 2. An oral wipe as defined inclaim 1, wherein the piece of material is configured so that when thesleeve is wrapped about the user's index finger, the sleeve extends atleast from the tip of the user's finger to a location that is past themiddle inter phalangeal joint of the user's index finger.
 3. An oralwipe as defined in claim 2, wherein the piece of material is furtherconfigured so that a distal end of the sleeve extends past the distaltip of the user's finger and can be bent back over the sleeve andcaptured between the user's thumb and the sleeve, to stabilize thedistal end on the sleeve and maintain the sleeve on the user's finger.4. An oral wipe as defined in claim 1, wherein the piece of material hasa parallelogram shape.
 5. An oral wipe as defined in claim 4, whereinthe parallelogram shaped piece of material has (i) parallel sides, eachof which has a length of at least 4 inches, (ii) a height of at least2.5 inches, and adjacent surfaces that form acute angle portions of 40to 70 degrees.
 6. An oral wipe as defined in claim 5, wherein the pieceof material is absorbent and the oral therapeutic solution includes anticariogenic agent and/or anti microbial agent.
 7. An oral wipe as definedin claim 3, wherein the piece of material is absorbent and the oraltherapeutic solution includes anti cariogenic agent and/or antimicrobial agent.
 8. An oral wipe as defined in claim 1, wherein the oraltherapeutic solution includes anti-cariogenic agent and/or antimicrobial agent.
 9. An oral wipe as defined in claim 1, wherein thesheet of material includes a pair of acute angle end portions provide anacute angle lead point for initiating wrapping about a user's indexfinger and an acute angle trailing point that overlies the remainder ofthe sleeve an which can be engaged by a user's thumb to stabilize thesleeve on the user's index finger.
 10. A method of handling an oralwipe, comprising the steps of, a. providing an oral wipe structurecomprising a piece of material in a predetermined folded condition, thepiece of material having a predetermined unfolded configuration andbeing impregnated with oral therapeutic solution, b. unfolding the pieceof material to its predetermined unfolded configuration, and c. wrappingthe piece of material about a user's index finger to form a sleeve aboutthe user's index finger, and applying pressure to the sleeve by theuser's thumb to stabilize the sleeve on the user's finger.
 11. A methodas defined in claim 10, wherein the step of wrapping the piece ofmaterial about a user's index finger comprises using a portion of thepiece of material as a lead point to initiate wrapping of the piece ofmaterial about a user's index finger and wrapping the piece of materialin a pattern that produces a trailing point that overlies the remainderof the sleeve and which can be engaged by a user's thumb to stabilizethe sleeve on the user's index finger.
 12. A method as defined in claim11, wherein a distal portion of the sleeve extends past the distal tipof the user's index finger, and the method includes bending the distalportion of the sleeve back over the sleeve and capturing the bent backdistal portion between the user's thumb and the sleeve, to stabilize thedistal end of the sleeve and maintain the sleeve on the user's finger.13. A method as defined in claim 12, wherein the unfolded configurationof the piece of material comprises a parallelogram.
 14. A wipecomprising a piece of material impregnated with a solution that isintended to be used as part of a wiping process, the piece of materialconfigured to be wrapped completely about a user's index finger toprovide a sleeve about the user's index finger, and further configuredso that when wrapped about a user's index finger an outer portion of thesleeve is oriented so that pressure from the user's thumb will stabilizethe sleeve and maintain the sleeve on the user's index finger.
 15. Awipe as defined in claim 14, wherein the piece of material is configuredso that when the sleeve is wrapped about the user's index finger, thesleeve extends at least from the tip of the user's finger to a locationthat is past the middle inter phalangeal joint of the user's indexfinger.
 16. A wipe as defined in claim 15, wherein the piece of materialis further configured so that a distal end of the sleeve extends pastthe distal tip of the user's finger and can be bent back over the sleeveand captured between the user's thumb and the sleeve, to stabilize thesleeve and maintain the sleeve on the user's finger.
 17. A wipe asdefined in claim 16, wherein the piece of material is configured suchthat the distal end of the sleeve can be bent back over and stabilizedagainst the middle or distal phalanx of the user's finger.
 18. A wipe asdefined in claim 16, wherein the piece of material has a parallelogramshape.
 19. A wipe as defined in claim 18, wherein the parallelogramshaped piece of material has adjacent surfaces that form a pair of acuteangle end portions, each acute angle end portion defining an acuteangle.
 20. A wipe as defined in claim 19, wherein the parallelogramshaped piece of material has (i) parallel sides, each of which has alength of at least 4 inches, (ii) a height of at least 2.5 inches, andadjacent surfaces that form acute angle portions of 40 to 70 degrees.21. A wipe as defined in claim 20 wherein the piece of material isfolded into a predetermined folded configuration in which at least oneof the acute angle end portions overlying the remainder of the foldedpiece of material and provides a convenient gripping portion to enablethe piece of material to be conveniently unfolded.
 22. A method ofhandling a wipe, comprising the steps of; a. providing a wipe comprisinga piece of material in a predetermined folded condition, the piece ofmaterial having a predetermined unfolded configuration and beingimpregnated with a solution, b. unfolding the piece of material to itspredetermined unfolded configuration, and c. wrapping the piece ofmaterial about a user's index finger to form a sleeve about the user'sindex finger, and applying pressure to the sleeve by the user's thumb tostabilize the sleeve on the middle phalanx of the user's finger.
 23. Amethod as defined in claim 22, wherein the piece of material includes apair of acute angle portions, and wherein the step of wrapping the pieceof material about a user's index finger comprises using one of the acuteangle portions as a lead point to initiate wrapping of the piece ofmaterial about a user's index finger and applying the other acute angleportion as a trailing point that overlies the remainder of the sleeveand which can be engaged by a user's thumb to stabilize the sleeve onthe middle phalanx of the user's index finger.
 24. A method as definedin claim 23, wherein a distal portion of the sleeve extends past thedistal tip of the user's index finger, and the method includes bendingthe distal portion of the sleeve back over the sleeve and capturing thebent back distal portion between the user's thumb and the sleeve, tostabilize the distal end of the sleeve and maintain the sleeve on theuser's finger.
 25. A method as defined in claim 24, wherein the unfoldedconfiguration of the piece of material comprises a parallelogram.
 26. Amethod of applying an anti-cariogenic, anti-microbial, anti-inflamatory,re-calcifying, dental whitening, mouth freshening, or topical anestheticmaterial to a patient's mouth, comprising providing an oral wipe that isimpregnated with an oral therapeutic solution, and applying pressure andwiping the wipe against the teeth, and against any or all of the gums,tongue, or mucosal surfaces of a patient's mouth.
 27. A method asdefined in claim 26 wherein the therapeutic solution includes ananti-cariogenic substance such as xylitol that may be applied to theteeth for the potential prevention of early childhood caries.
 28. Amethod as defined in claim 26, wherein the oral therapeutic solutionincludes an antimicrobial material that includes nystatin for thetreatment of oral candidiasis
 29. A method as defined in claim 26,wherein the therapeutic solution includes a topical anesthetic,including benzocaine, which may be applied to the teeth and gums for thetreatment of teething pain.